While considering the notions of staring down ‘magic microscopes’ and sniffing out DNA in test tubes, the High Court of Australia has granted special leave to appeal the decision of the full bench of the Federal Court of Australia in the highly publicised matter between Myriad and Yvonne D’Arcy relating to the patentability of genes.
Last year, in a very carefully worded unanimous decision, the five judge bench of the Federal Court upheld the patentability of claims directed to ‘an isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide..’, in one of Myriad Genetics BRCA patents which claims both breast cancer diagnostics methods and BRCA DNA molecules.
At that time, the applicant, cancer survivor Yvonne D’Arcy, submitted to the Federal Court that these BRCA genes exist in nature and are therefore not patentable subject matter. It was generally thought that the High Court might take the case only so that, in this very controversial area of public interest, the matter could be resolved once and for all. However, the ‘public interest’ was not mentioned once by either legal team. Ms D’Arcy’s legal team, leveraging the decision on the parallel matter in the US Supreme Court case continues to run a similar argument in last Friday’s request for special leave to that which they ran in the Federal Court. The US Supreme Court in a split decision found that an isolated gene is not patentable subject matter as it is a product of nature.
In their submissions to the High Court, Myriad reminded the bench that one must not look at a ‘product and compare it and contrast it with nature for the purpose of determining whether it falls within a “laws of nature” exception [which exists in US law, but not in Australian law] but, rather, you look at the product and ask the NRDC question – is the product artificial?’ Specifically, Myriad asserted again that the isolated gene is structurally, functionally and chemically different and is therefore not natural. This argument was successful in the lower court.
However, D’Arcy argued that despite the DNA ‘not being wrapped around histones in the cell’, the structure of the sequence, the sequence of nucleotides from which it can be determined whether or not the person is susceptible to cancer, is the same both in nature and in an isolated gene.
Bell, J summarised the argument as being whether ‘the economic value is to the same genetic information as occurs in nature’ and ‘whether the product is relevantly an artificial state of affairs’.
High Court proceedings have been listed for April this year.